New Lung Cancer Drug Augtyro is Now Available

Bristol Myers Squibb has launched Augtyro (repotrectinib), the newly approved drug to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). ROS1 fusions are rare and occur in about 1% to 2% of patients with NSCLC, but these cancers tend to be more aggressive and can spread to the brain.

Augtyro is an oral tyrosine kinase inhibitor (TKI) that is designed to minimize interactions that can lead to certain forms of treatment resistance in ROS1-positive metastatic NSCLC patients. Augtyro was developed by Turning Point Therapeutic, which Bristol Myers Squibb acquired in 2022.

The FDA had approved Augtyro last month. The wholesale acquisition cost (WAC) for an adult is $29,000 based on 30-day supply of 160 mg twice a day.

BMS officials said they are meeting with payers about coverage of Augtyro. The BMS Access Support program provides resources to help patients understand their insurance coverage and find information on sources of financial support, including co-pay assistance for eligible commercially insured patients. 

The BMS Access Support Co-pay Assistance Program assists with out-of-pocket co-payment or co-insurance requirements for eligible, commercially insured patients who have been prescribed certain Bristol Myers Squibb products, including Augtyro. Patients with commercial insurance may be eligible for a $0 co-pay offer through the BMS Access Support Co-Pay Assistance Program, which has an annual maximum benefit of $15,000.

Medicare Part D patients without the low income subsidy pay a total of about $3,333 a year using 2024 Medicare Part D benefit design thresholds.

Related: FDA Approves Augtyro to Treat ROS1 Positive Lung Cancer

The approval is based on the TRIDENT-1 study, which was an open-label, single-arm, phase 1/2 trial that evaluated Augtyro in 71 TKI-naïve and 56 TKI-pretreated patients. For TKI-naïve patients, the primary endpoint of objective response rate was 79%. The median duration of response was 34.1 months.

Jessica J. Lin, M.D.

“New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, M.D., TRIDENT-1 primary investigator and attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital and Assistant Professor of Medicine at Harvard Medical School, said. “Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer.”